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Batch‐to‐batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial

Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch‐to‐batch variability in study design or analysis. Here we evaluate the magnitude of batch‐to‐batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administ...

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Detalhes bibliográficos
Publicado no:Clin Pharmacol Ther
Main Authors: Burmeister Getz, E, Carroll, KJ, Jones, B, Benet, LZ
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5102576/
https://ncbi.nlm.nih.gov/pubmed/27037630
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.373
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